Biotechnology Update
Internal Co-ordination Group for Biotechnology (ICGB)
No. 17, December 2006
This newsletter provides up-to-date information on OECD activities related to biotechnology. It is mainly
intended for delegates to OECD meetings who are already familiar with certain aspects of OECD’s work.
We hope that it is also informative for the wider biotech community. This edition also addresses OECD
work related to nanotechnologies and the safety of manufactured nanomaterials.
The contents of this newsletter have been provided by those members of the OECD secretariat who are
responsible for the various activities. Members of the secretariat can be contacted via the e-mail address:
icgb@oecd.org .
Alternatively, individuals can be contacted via e-mail using the form
firstname.lastname@oecd.org .
This edition is now available on the Internet as a “live-link” version.
Table of Contents
ABOUT OECD’S INTERNAL CO-ORDINATION GROUP FOR BIOTECHNOLOGY (ICGB) .................................. 2
OECD COUNTRIES AGREE GUIDELINES ON LICENSING OF HEALTH CARE GENETICS ................................ 2
GUIDELINES ON THE CREATION AND GOVERNANCE OF HUMAN GENETIC RESEARCH DATABASES .... 3
COLLABORATIVE MECHANISMS FOR THE MANAGEMENT OF INTELLECTUAL PROPERTY (IP) ............... 4
COUNTERFEITING AND PIRACY OF PHARMACEUTICALS ................................................................................... 4
BIOTECHNOLOGY PATENT CLASSIFICATIONS....................................................................................................... 5
THE BIOECONOMY TO 2030: DESIGNING A POLICY AGENDA............................................................................. 5
SPECIALISATION, REGIONAL CLUSTERS AND COMPETITIVENESS .................................................................. 6
PLANNED OECD WORKSHOP ON BIOENERGY POLICY ANALYSIS .................................................................... 7
HARMONISATION OF REGULATORY OVERSIGHT IN BIOTECHNOLOGY ......................................................... 7
BIOTRACK ONLINE ........................................................................................................................................................ 8
SAFETY OF NOVEL FOODS AND FEEDS .................................................................................................................... 9
POLICY COHERENCE FOR THE AVAILABILITY OF MEDICINES FOR EMERGING AND NEGLECTED
INFECTIOUS DISEASES ............................................................................................................................................... 10
THE IMPACTS OF PHARMACOGENETICS ON HEALTH - INNOVATION AND DELIVERY ............................. 11
EMERGING RESEARCH MODELS FOR THE DELIVERY OF HEALTH INNOVATION ....................................... 11
HEALTH INNOVATION SURVEY ............................................................................................................................... 12
CASE STUDIES ON THE UPTAKE AND DIFFUSION OF HEALTH RELATED BIOTECHNOLOGIES ............... 13
OECD INVITES PUBLIC COMMENTS ON GUIDELINES FOR QUALITY ASSURANCE IN MOLECULAR
GENETIC TESTING........................................................................................................................................................ 13
BIOLOGICAL RESOURCE CENTRES ......................................................................................................................... 14
THE OUTLOOK FOR INDUSTRIAL BIOTECHNOLOGY .......................................................................................... 15
BIOSECURITY ................................................................................................................................................................ 15
BIOTECHNOLOGY STATISTICS IN OECD MEMBER COUNTRIES....................................................................... 16
MEASURING THE OUTPUTS AND IMPACTS OF BIOTECHNOLOGY WORKSHOP ........................................... 16
CO-OPERATIVE RESEARCH PROGRAMME (CRP): BIOLOGICAL RESOURCE MANAGEMENT FOR
SUSTAINABLE AGRICULTURAL SYSTEMS' ........................................................................................................... 17
OECD'S SEED CERTIFICATION AND FOREST REPRODUCTIVE MATERIAL SCHEMES ................................. 18
OECD BIOTECHNOLOGY AND THE WORLD WIDE WEB ..................................................................................... 19
NANOTECHNOLOGIES AND THE SAFETY OF MANUFACTURED NANOMATERIALS ................................... 20
COMMITTEE FOR SCIENTIFIC AND TECHNOLOGICAL POLICY (CSTP) ....................................................... 20
CHEMICALS COMMITTEE: WORKING PARTY ON MANUFACTURED NANOMATERIALS (WPMN) ....... 20
FUTURE EVENTS .......................................................................................................................................................... 21
WHO’S WHO IN BIOTECH AT OECD ......................................................................................................................... 22
CONTACT POINT:.......................................................................................................................................................... 23
MEDIA ENQUIRIES: ...................................................................................................................................................... 24
ENDNOTE: A BRIEF GUIDE TO THE OECD .............................................................................................................. 24
ABOUT OECD’S INTERNAL CO-ORDINATION GROUP FOR BIOTECHNOLOGY (ICGB)
OECD and its member countries have been addressing issues related to biotechnology since 1982.
Since that time, biotechnology has had an increasing impact on the programmes of different sectors at OECD
such as: agriculture; science, technology, and industry; environment; and trade. So in 1993, the Internal Coordination Group on Biotechnology (ICGB) was established to facilitate co-ordination among these sectors.
More recently, there has been much public discussion about the potential of nanotechnologies, which are set
to offer a wide range of economic benefits. Such technologies pose new policy challenges to governments,
which will require a robust framework of policy and safety. The OECD is working on efficient policies and
effective instruments that foster the safe development of nanotechnologies.
The Directorates involved in work related to nanotechnologies and nanomaterials agreed that the ICGB
would be the appropriate forum to co-ordinate OECD work on these emerging issues. Work in both areas
involves the same OECD Directorates as the work on biotechnologies, notably SGE/AU, STI and ENV. At
the same time, there are similarities to the work on biotechnology, e.g. with respect to the multidisciplinary
approach needed to address the policy issues in these areas. For this reason, this newsletter includes a section
devoted to nanotechnologies/ nanomaterials.
Michael Oborne, the Director of OECD’s Advisory Unit on Multidisciplinary Issues and the International
Futures Programme, chairs the ICGB. Peter Kearns, the Head of OECD’s Biosafety Programme, is the
Secretary.
Contact:
Peter Kearns
OECD COUNTRIES AGREE GUIDELINES ON LICENSING OF HEALTH CARE GENETICS
Biotechnology and genetics research have been the subject of extensive investment by both the public and
private sectors, with the products and processes emerging from these efforts making a significant and
increasing contribution to human health and health care. Moreover, biotechnological, including genetic,
innovations have been the subject of intellectual property rights for decades. Over the last decade, as the
number of such innovations has increased, their impact on health care has grown substantially.
Recently, some governments, patient groups and healthcare providers have become concerned about how
certain genetic inventions have, in certain circumstances, been licensed and exploited, particularly for
diagnostic genetic services in the human health care field.
In order to address these concerns, OECD member countries agreed to Guidelines for the Licensing of
Genetic Inventions which were adopted by the OECD Council as a Recommendation in February 2006.
The Guidelines offer principles and best practices for the licensing of intellectual property rights that relate
to genetic inventions used for the purpose of human health care. These Guidelines are targeted at those
involved with innovation and the provision of services in health, and particularly at those involved in the
licensing of such inventions. Overall, the Guidelines seek to foster the objectives of stimulating genetic
research and innovation while maintaining appropriate access to health products and services.
2
These Guidelines may be obtained on our website.
Web site:
www.oecd.org/sti/biotechnology/licensing (English),
www.oecd.org/sti/biotechnologie/licences (French)
http://www.oecdtokyo.org/theme/bio/2006/20060301healthcaregenetics.html (Japanese)
Contact:
Christina Sampogna
GUIDELINES ON THE CREATION AND GOVERNANCE OF HUMAN GENETIC RESEARCH
DATABASES
Scientists have known for years that complex diseases, such as cancer, heart disease, stroke, and diabetes,
arise from a combination of lifestyle, environmental, genetic and random factors. Large-scale study of
populations may contribute significantly to science’s understanding of the complex multi-factorial basis of
disease and to improvements in prevention, detection, diagnosis, treatment and cure. As a result of
developments in biotechnology and bioinformatics, the opportunity to store and analyse increasingly large
amounts of genetic data have rendered possible the creation of large-scale population databases.
Large-scale population databases which contain a significantly broader range of information about
individuals also raise a number of issues and concerns. While some of these are not new, the increasing
breadth and scope of such databases amplifies them. Moreover, the combination of a broader set of genetic
data and personal information in these databases raises new issues about the use of such information,
especially in a non-clinical or non-research context. As such databases will increasingly be international in
scope, and cover populations from numerous jurisdictions, new sets of questions will also arise.
A report, entitled Creation and Governance of Human Genetic Research Databases, has just been published
It provides an overview of the complex issues which need to be considered or addressed, in recognition of
the significant contribution that human genetic research databases could play in translating scientific
advances into innovation in health.
Work is also underway to elaborate guidelines on the establishment, management and governance of human
genetic research databases. The guidelines are being developed by OECD member countries and their
national experts. The aim of these guidelines is to develop principles and best practices on the numerous
issues that arise with respect to HGRDs. The wide range of issues include funding mechanisms, governance
structure, privacy and confidentiality policies, commercialisation consideration, security of databases, etc.
Web site: www.oecd.org/sti/biotechnology
Recent Publication:

Report entitled Creation and Governance of Human Genetic Research Databases
Contact:
Christina Sampogna
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COLLABORATIVE MECHANISMS FOR THE MANAGEMENT OF INTELLECTUAL
PROPERTY (IP)
Recently, both industry and governments have considered factors and mechanisms for encouraging
collaboration amongst diverse interests in order to stimulate innovation, foster R&D and promote access and
diffusion of technology and information. Previously, some collaborative mechanisms have been employed
within other areas, such as information technology. However, there is increasing consideration and
discussion about their potential use within the life sciences.
Although the discussion of using such mechanisms in the life sciences is fairly recent, certain organisations
have recommended that governments, the public sector and the private sector consider the development and
use of collaborative mechanisms, within the life sciences and the field of biotechnology. The organisations
who have made such recommendations include the Australian Law Reform Commission, the Canadian
Expert Working Party on Human Genetic Materials, Intellectual Property and the Health Sector (Canadian
Biotechnology Advisory Committee), the United States National Academies of Science (US), and the
OECD. Consideration of these types of mechanisms is also occurring within the private sector, wherein
companies, such as Pfizer, GlaxoSmithKline and Affymetrix, are also studying the use of such mechanisms
for fostering innovation.
A high-level roundtable was organised with experts from diverse backgrounds and experiences including
private sector, public sector, finance, biotechnology/pharmaceutical/science, management, legal (IP, antitrust/ competition), research/academia, etc. Generally, the roundtable focused on the diverse types of
collaborative mechanisms and the manner in which they may be employed to facilitate access to and use of
biotechnological innovations for purposes of research, commercialisation and the provision of
products/services. An analytical report is being written that will draw on the roundtable discussion and will
provide an overview of the issues pertaining to collaborative mechanisms and their application in the life
sciences. The aim is to publish this report in 2007.
Contact:
Christina Sampogna
COUNTERFEITING AND PIRACY OF PHARMACEUTICALS
In response to rising concerns in government and the business community, the OECD has launched a project
that will assess the effects of counterfeiting and piracy on economies. The objective of the project is to
improve factual understanding and awareness of the effects that counterfeiting and piracy of intellectual
property rights have on governments, business and consumers in member countries and non-member
economies. This project will focus on counterfeit and pirated products from an intellectual property
perspective (i.e. tangible products that infringe trademarks, copyrights, patents and design rights).
Within this first phase, a number of sectoral case studies will be conducted, illustrating the various forms of
counterfeiting and piracy, and the effects on producers, consumers and governments. The pharmaceutical
sector has been identified as one sector, since counterfeiting of medicines has significant safety, health,
social implications, as well as economic ones. A sector report on the counterfeiting and piracy of
pharmaceuticals will be part of the OECD project covering the economic and social impact of counterfeiting
and piracy.
A separate and second report focusing solely on the counterfeiting of pharmaceuticals, from a broader, public
health perspective, is also being produced. The report will examine the diverse definitions of counterfeit
pharmaceuticals, the nature and scope of counterfeiting activities, the modes of operation, assess the trends
and magnitude, evaluate the impacts on patients/consumers, especially public health implications, on the
private sector and on governments, and analyse measures employed for combating counterfeiting of
pharmaceuticals (including, technology, legislative and regulatory mechanisms, education and risk
4
communication, enforcement, securing of distribution/supply chain, and international cooperation).
Anticipated publication date is 2007.
Contact: Christina Sampogna
BIOTECHNOLOGY PATENT CLASSIFICATIONS
Within patent classification systems, some technologies or scientific fields have a set of patent codes that are
uniquely applicable to them. However, this is not the case for the field of biotechnology. There is no
category of patent codes established for the field of “biotechnology”. Rather, the codes used for patent
applications in the field of biotechnology are drawn across a number of fields. In order to carry out statistical
analysis based on patent information, there is a need to develop a definition of “biotechnology patents”. Over
the past few years, work has been carried out within the OECD to develop a provisional definition of
‘biotechnology patents’ through the identification of codes that may cover the field of biotechnology. The
codes for the OECD provisional definition for biotechnology patents are drawn from the International Patent
Classification (IPC) system established and managed by the World Intellectual Property Organisation
(WIPO).
The OECD intends to broaden out its statistical and economic analysis of developments and innovation
pertaining to the field of biotechnology. Indicators based on biotechnology patents may be one component
for carrying out such analysis and may provide some further insight into the level of biotechnology activities
across the OECD countries. In light of this, ensuring an accurate definition of “biotechnology patents” is
essential. Thus further work is being carried out to update and refine the previous “biotechnology patents”
definition. The development of this definition is being carried out through consultation and collaboration
with diverse stakeholders, including patent offices, government policy-makers, intellectual property
practitioners, intellectual property associations, biotechnology and life sciences companies and associations,
university technology transfer offices, researchers, international organisations, etc. It is intended that the
definition of “biotechnology patents” be made public in 2007.
Contact:
Christina Sampogna
THE BIOECONOMY TO 2030: DESIGNING A POLICY AGENDA
The bioeconomy is the set of economic activities relating to the invention, development, production and use
of biological products and processes. While still relatively small, development is occurring rapidly. In the
future, biotechnology is expected to contribute significantly to the overall economy and society as a whole.
It will do this by improving health outcomes, nutrition, energy efficiency, the environment, and industrial
processes, as well as enhancing sustainability and improving human welfare more generally. But the promise
of biotechnology and the bioeconomy must be nurtured and fostered by judicious policy choices ranging
from long term investment to appropriate regulatory frameworks. Consumer understanding, confidence and
acceptance of the new possibilities are also necessary to the growth that pervasive and generic biotechnology
will provide.
The International Futures Programme (IFP) of the OECD specialises in analysing key long-term trends to
help governments map strategy and projects. Due to the rapid increase in biological innovation, growing
strategic interest in the bioeconomy (in OECD and non-OECD areas) and its potential for significant global
economic, social and environmental benefits, the IFP has launched a two-year project on The Bioeconomy to
2030: Designing a Policy Agenda.
5
Following a year-long consultation process with representatives from governments, the private sector and
research institutions, the IFP has begun building a Steering Group to help guide the project. At the group’s
first meeting on 17th November 2006, participants were provided with draft documents that analyse the
biotechnology market and product structure, the regulatory tools and frameworks in biotechnology, and
current OECD work on biotechnology statistics and indicators. After discussing the baseline provided by the
draft papers, the group discussed the geographic and sectoral scope and potential outcomes of the project.
The Steering Group will meet three more times to focus and review work before the end of the project in
early 2008.
Through the collaborative work of the Steering Group, IFP Staff, related OECD directorates, and external
experts, the project will pursue several objectives:
 Assess the long-term prospects of the bioeconomy over the next thirty years and its economic and
social implications.
 Improve the indicators and metrics that are needed to monitor the development of the bioeconomy.
 Identify the most critical issues that may affect the medium- and longer-term prospects for the
bioeconomy (e.g. technical, financial, human capital, and regulatory bottlenecks).
 Explore the value chain, emerging new business models and scope for co-operation among
stakeholders.
 Identify where policies and regulations are increasingly out of step with biotechnology
development and propose options for a more dynamic policy framework.
 Seek ways to make the concept of the bioeconomy and its potential more robust and concrete.
 Further other work on the bioeconomy within the OECD
For further details please consult the project brochure: http://www.oecd.org/dataoecd/7/51/37504590.pdf
Contacts: Michael Oborne
Iain Gillespie
David Sawaya
SPECIALISATION, REGIONAL CLUSTERS AND COMPETITIVENESS
Thanks to useful background information and well-organised missions by participating regions, the regional
strategies study is now under way.
The regional strategies study looks at approximately 12 regions within the Biotech, ICT and Automotive
sector and participating region within the Biotech sector are Stockholm/Malar region, Northern Switzerland
(Basel), Montreal and Shanghai.
Each region prepared a questionnaire “self-assessment” which was followed up by a sector expert and a
representative from the OECD/Nutek project team. Interested interviews was been held with people from the
industry, university and the public sector discussing for example the role of the Biotech sector, regional
strategies, main characteristics of cluster policies and other key instruments, distribution of roles and
cooperation between levels and sectors, research productivity etc.
A regional strategies report based on self-assessments, missions and a global outlook prepared by the
International Future Studies Programme will be delivered by our sector experts in December. The
OECD/Nutek project team will then integrate the three regional strategies reports (Biotech, ICT and
Automotive) into a final Regional Strategies Report with policy recommendations of general value for all
OECD countries.
The findings will be presented at an international conference in Stockholm in May 2007.
Contact: Andrew Davies
6
PLANNED OECD WORKSHOP ON BIOENERGY POLICY ANALYSIS
In the context of the 2007-08 Programme of Work and Budget, the Directorate for Food, Agriculture and
Fisheries (AGR) is organising a Workshop on Bioenergy. The OECD Workshop on Bioenergy Policy
Analysis, in co-operation with the CRP and hosted by Sweden, will be held in Umea on 22-23 January 2007.
The main focus of the workshop will be to take stock of the current situation with respect to bioenergy
research and to define in more detail the implementation of further work on the subject of bioenergy, as
envisaged in the Programme of Work and Budget of the Committee for Agriculture for 2007-2008, with a
particular focus on the link between bioenergy policies and agricultural markets.
Speakers in three main sessions will provide up-to-date information on the different dimensions of bioenergy
developments, i.e. from the scientific, environmental, policy and economic perspective. The list of
participants will include Speakers from Utrecht University, the European Environment Agency, the Global
Subsidies Initiative, the Institut National des Recherches Agricoles, the European Commission, the
International Energy Agency, Agriculture and Agri-Food Canada, the Rabobank, and the Iowa State
University, but active input is seeked from many other participants. A final panel discussion in the fourth
session will condense the findings of the workshop and build the bridge to future work.
Contact: Martin von Lampe
HARMONISATION OF REGULATORY OVERSIGHT IN BIOTECHNOLOGY
The main focus of OECD’s Working Group on Harmonisation of Regulatory Oversight in Biotechnology is
on environmental risk/ safety assessment of transgenic (genetically modified) crops. The work aims to
ensure that the information used in risk/ safety assessment, as well as the methods used to collect such
information, is as similar as possible. This improves mutual understanding amongst countries, increases the
efficiency of the risk/safety assessment process and avoids duplication of effort, while reducing barriers to
trade.
The participants of the Working Group are mainly from those government ministries and agencies, which
have responsibility for the environmental risk/ safety assessment of products of modern biotechnology.
There are also a number of observer delegations and invited experts who participate in the work. They
include: Argentina; Russia; Slovenia; the Secretariat of the Convention on Biological Diversity (SCBD); and
the Business and Industry Advisory Committee to OECD (BIAC). During the last couple of years, there has
been increased participation of other non-member countries including Brazil, Cameroon, Chile, China,
Egypt, India and Philippines, under the auspices of OECD’s Global Forum on the Knowledge-based
Economy.
During 2006, the OECD organised a series of events for the 20th anniversary of the publication of
Recombinant DNA Safety Consideration (commonly called as Blue Book) which was the first
intergovernmental activity on the environmental safety of transgenic organisms. These events included: a
side-event of the 3rd Meeting of the Parties to the Cartagena Protocol (MOP3); a special focus session of the
18th meeting of the Working Group; and a workshop held in conjunction with the 9 th International
Symposium on Biosafety of Genetically Modified Organisms. Amongst other things, the workshop was an
important opportunity to have inputs and a perspective of those who rarely participate in OECD meetings on
the OECD’s activities. The summary of the workshop will be published in a special edition of the journal,
Environmental Biosafety Research.
7
The publication of Consensus Documents continues to be a major output of the work of the Working Group.
To date, 27 Consensus Documents including those for the biology of crops, trees and micro-organisms, and
for selected traits that may be introduced into crop species, as well as the other variety of documents useful
for risk/ safety assessment, have been published. All of them are available through the website
(http://www.oecd.org/biotrack). In addition, a two-volume compilation book including all of the published
Consensus Documents, Safety Assessment of Transgenic Organisms: OECD Consensus Documents, was
recently
published.
This
can
be
purchased
through
OECD’s
online
bookshop
(http://www.oecdbookshop.org/).
Future events:
 19th Meeting of the Working Group for the Harmonisation of Regulatory Oversight in
Biotechnology, Paris, 21-23 February 2007.
Recent Publications:
 Points to Consider for Consensus Document on the Biology of Cultivated Plants
 Consensus Document on the Biology of Capsicum annuum complex
 Consensus Document on Information Used in the Assessment of Environmental Applications involving
Acidithiobacillus
 Report of the OECD Expert Workshop on the Biology of Atlantic salmon (salom salar), Moscow 29
November-1 December 2004.
 Consensus Document on the Biology of Western White Pine
 Consensus Document on the Biology of Jack Pine
 Safety Assessment of Transgenic Organisms: OECD Consensus Documents Volume 1 and 2
 Revised 2006: OECD Guidance for the Designation of a Unique Identifier for Transgenic Plants
Web site:
BioTraxk Online (http://www.oecd.org/biotrack)
Contacts:
Peter Kearns
Masatoshi Kobayashi
Mar Gonzalez
BIOTRACK ONLINE
BioTrack Online information system is a mechanism by which the Working Group on Harmonisation in
Biotechnology and the Task Force for the Safety of Novel Foods and Feeds make available the outputs of
their work. It also includes a Product Database of transgenic products which have been approved for
commercial use in OECD member countries (mainly transgenic crops).
The recent major output is the development of a unique identification system for transgenic crop plants. Its
Unique Identifier has been used as "keys" to access information of each transgenic product in the Product
Database (http://www.oecd.org/biotrack/productdatabase), and has been globally recognised as an
appropriate identification system of products included in the Biosafety Clearing-house (BCH) of the
Cartagena Protocol on Biosafety.
The Working Group recently agreed on how to assign a Unique Identifier to products with stacked events. A
revised guidance document on the unique identification system which has reflected this agreement has been
published. The Working Group has currently discussed how to develop a unique identification system for
transgenic micro-organisms.
Web site:
BioTrack Online
http://www.oecd.org/biotrack
8
Product Database and Unique Identifiers
http://www.oecd.org/biotrack/productdatabase
Contact:
Masatoshi Kobayashi
SAFETY OF NOVEL FOODS AND FEEDS
The work of OECD’s Task Force for the Safety of Novel Foods and Feeds remains focused on the promotion
of harmonisation in the safety assessment of novel foods and feeds. Its main output remains its consensus
documents, which addresses the safety of novel products, from a human food and animal feed safety
perspective. These documents compile information on the major nutrients, toxicants, anti-nutrients and
allergens of specific food/feed crops, which is critical to their safety assessment. To date 11 consensus
document addressing major crops have been completed and published: Low Erucic Acid Rapeseed; Soybean;
Sugar Beet; Potatoes; Maize; Bread Wheat; Rice; Cotton; Barley; Alfalfa and other Temperate Forage
Legumes. In addition, the Task Force published a document on Considerations for the Safety Assessment of
Animal Feedstuffs derived from Genetically Modified Plants, and An Introduction to the Food/Feed Safety
Consensus Documents of the Task Force. Also, two documents will be shortly declassified on Sunflower and
Agaricus bisporus (mushroom), and three additional documents are currently under preparation on Tomato,
Papaya, and Cassava. Furthermore, during the recent 12th Meeting of the Task Force that was held 13-15
September in Athens, Greece, a consensus document on sweet potato was proposed. South Africa and Japan
will co-lead in the drafting of this document.
The Task Force has also made progress in deciding the next steps to review and update (if necessary)
previously published consensus documents. To this end, two documents will be reviewed at the 13th Meeting
of the Task Force to be held in June 2007.
Delegates to the Task Force are typically from those ministries and agencies, which have responsibility for
the safety of transgenic products, from a human food and/ or an animal feed perspective. On the other hand,
as modern biotechnology has become an increasingly global issue, one of the main features of the Task
Force has been the increasing participation on non-member economies and invited experts to its work. The
Task Force benefits from the participation of delegations from: Argentina, Brazil, China, Latvia, the Russian
Federation, Slovenia, South Africa and Thailand. Their participation has been possible through the Global
Forum on the Knowledge-based Economy (GFKE) under the auspices of OECD’s Centre for Co-operation
with non-members. Participation also involves the Codex Alimentarius Commission, FAO/WHO and BIAC.
This dialogue has shown that the consensus documents are useful and used by non-members as well as
member countries. The Task Force continues to involve more actively the expertise and interests of non
member economies. This broadens the expertise that is available to the Task Force, while addressing a wider
range of food and feed products that are of global interest. As a consequence, Thailand and South Africa
have now started to work on two consensus documents on compositional considerations for papaya and
cassava. Both crops are of high importance for their respective countries, as well as many other members and
non-members. These consensus documents are being drafted in co-operation with delegations from OECD
member countries.
Finally, the Task Force is carrying out jointly with the Working Group on Harmonisation of Regulatory
Oversight in Biotechnology a project on Molecular Characterisation for Transgenic Plants. It is expected that
the first draft of the document will be completed at the beginning of 2007 for consideration by both the
Working Group and the Task Force.
Forthcoming Event:

13th Meeting of the Task Force for the Safety of Novel Foods and Feeds, Paris, France, 27-29 June
2007
9
Upcoming Publication:


Consensus Document on Compositional Considerations for New Varieties of the Cultivated Mushroom
Agaricus bisporus: Key Food and Feed Nutrients, Anti-Nutrients and Toxicants
Consensus Document on Compositional Considerations for New Varieties of the Sunflower: Key Food
and Feed Nutrients, Anti-Nutrients and Toxicants
Web site:
BioTrack Online (http://www.oecd.org/biotrack)
Contact:
Mar Gonzalez
POLICY COHERENCE FOR THE AVAILABILITY OF MEDICINES FOR EMERGING AND
NEGLECTED INFECTIOUS DISEASES
The issue of availability, accessibility and affordability of medicines for emerging and neglected diseases is a
thorny topic that is a source of friction between the developed and developing world. Disease burden is
undeniably a major stumbling block to economic and social progress in many developing countries, notably
in Africa. Since R&D, pharmaceutical production capabilities and intellectual property are based principally
in OECD countries these countries are in a special position to help address the health problems of the poor
globally. Indeed, the development of preventive treatments or therapies for infectious diseases is seen by
many groups as a global public good.
The OECD can play a role in helping its member countries understand how to improve policy signals so as to
encourage innovators to bring products that address neglected and emerging diseases – often diseases of
poverty – to the market. The goal of this project is to produce a sound analytical basis for action by Member
countries on improving the availability of medicines for emerging and neglected diseases and to increase
policy coherence within governments.
Two background papers have been developed by well known academics (Jeffrey Sachs of Columbia
University and Michael Kremer of Harvard University). The first focuses on the economic burden of
infectious disease, the second on the options for how the cost of innovation for new products can be borne so
as to improve the availability of medicines in developing countries. The background papers will provide the
intellectual basis for a High Level Forum amongst ministers and high level officials in countries,
international organisations, and philanthropies about how policy coherence could be improved on this topic
and what OECD countries could jointly or individually do to encourage investments in development of
vaccines and affordable therapies for the major infectious diseases. The High Level Forum is tentatively
scheduled to take place in the Netherlands in June 2007.
The project is under the Horizontal Project on Policy Coherence and is a cooperation between the
Development Cooperation Directorate and the Directorate for Science, Technology and Industry.
Contact:
Bénédicte Callan
Alexandra Trzeciak-Duval
10
THE IMPACTS OF PHARMACOGENETICS ON HEALTH - INNOVATION AND DELIVERY
An OECD workshop addressing international perspectives on pharmacogenetics was held in Rome, on
October 17-19 2005.
The workshop, co-sponsored by the Italian and Canadian Governments was held against a background of
growing concerns around the safety and efficacy of new and existing drugs, and the falling productivity of
the pharmaceutical R&D process.
Today it takes on average up to 12 years and about USD 800 million to bring a drug to the market. Much of
this represents the costs of early failures. Of the 5,000 to 10,000 compounds screened by a researcher in a
pharmaceutical company laboratory, only one will ever become a medicine. The economic burden of adverse
drug reactions to health care systems is also significant: for example, in the United States the cost of
drugrelated morbidity and mortality exceeded USD 177.4 billion in 2000.
Pharmacogenetics can offer solutions as it provides new ways of understanding how drugs work and how
this affects both their safety and efficacy. The opportunities from such understanding are considerable,
particularly in driving a more efficient and effective clinical research and innovation enterprise.
The aim of the workshop was to stimulate cross-sectoral exchange on progress in the field, experience in
regulatory approaches, economic impact assessment, and public-private sector co-operation. The audience
comprised 130 representatives from regulatory agencies, industry, patients' organisations and health policy
departments as well as health economists, academic researchers and clinicians.
Consensus was reached at the workshop on the potential of pharmacogenetics to offer new and exciting
opportunities for drug development and health care.
Speakers presented examples of successful applications of pharmacogenetics (most notably the use of the
anti-breast cancer drug Herceptin) where pharmacogenetics is influencing drug development, trials, safety
and use today and improving the evidence linking interventions to successful health outcomes.
There was consensus too that, in general, health policy making is simply not keeping up with the
implications of pharmacogenetics (and the use of biomarkers in evidence based medicine more generally).
Outputs from this workshop will form part of a policy report that will focus on the likely impacts of
pharmacogenetics on health innovation and delivery, as well as on the policy choices that countries will need
to make to respond to these developments.
Web site: An international perspective on pharmacogenetics: the intersection between innovation, regulation
and health delivery- Rome, Italy-17-19, 2005
http://www.oecd.org/document/16/0,2340,en_2649_34537_35517584_1_1_1_1,00.html
Contact: Elettra Ronchi
EMERGING RESEARCH MODELS FOR THE DELIVERY OF HEALTH INNOVATION
This project explores the range of novel initiatives for discovery research, development and delivery of
biomedical innovations which share a common goal of more rapidly and effectively bringing biomedical
products and processes from invention to market. Across the OECD there are dozens of such initiatives that
11
take a bench-to-bedside perspective on the delivery of health innovation. The tools used include the creation
of novel organisational networks and structures to increase flows of information among all stages of the
innovation cycle; the smarter use of information technology and the better exploitation data for both R&D
and clinical practice; the creation of new and convergent scientific infrastructures; strategies and financing
for improving the translation of discoveries into potential products; and the modernisation of clinical trials
and regulations.
Four Case studies illustrating the range of these initiatives were commissioned for an Expert Workshop that
was held in Paris on 20-21 November 2006. Discussion at the workshop identified areas in which
governments could support efforts under way. Participants mentioned the role of government in: providing
vision and leadership to effect a change in culture about health innovation; creating metrics of spending on
health innovation and its delivery; supporting the creation of a knowledge market for precompetitive
exchange of data and technologies; identifying new models to leverage IP in collaboration; validating proof
models; understanding the challenges and opportunities from technological convergence in health
innovation; analyzing how the value chain is changing in health innovation and policy interventions to
deliver on such new value chains
A Policy Report based on the case studies and the expert workshop discussion will be developed for the
Spring 2006 that will discuss the tools, incentive structures, or good practices used to speed up the time it
takes for laboratory discoveries to be translated into new medical treatments and where governments may
have a role.
Web site:
Contact:
www.oecd.org/biotechnology
Bénédicte Callan
Jack Radisch
HEALTH INNOVATION SURVEY
The links between innovation, productivity, health and wealth are recognised by OECD countries. But for
many countries, while investing in and encouraging innovation is a priority so is maintaining the
affordability, quality and sustainability of healthcare systems. The apparent tension between these two goals
can be mitigated. To help meet this policy challenge, the OECD conducted an eight country survey which
explored whether and how countries are trying to deliver greater convergence between healthcare priorities
and the direction of health innovation.
The survey was meant to explore what the mechanisms are by which the objectives of the health sector and
other specific health care goals influence the way in which governments develop policies to promote
innovation and improvements in quality in the health sector. The survey report, which will be available in
Spring 2007, will:
1)
Outline how various governments, government departments and other important agencies define
innovation in health care
2)
Document the government programs that aim to promote innovation in the health sector, to
stimulate the development of new innovations in health care and to coordinate these efforts.
3)
Document the range health care system priorities and policies, health objectives and other special
(political and social) circumstances that motivate government policies to promote and intervene in health
care innovation.
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Countries involved in the Survey – Canada, France, Germany, Japan, Mexico, the Netherlands, Norway and
the United States – will meet on December 8 to discuss their individual survey results and the conclusions
that can be drawn from the interviews more broadly.
This project was conducted for the Group on Health with input from the Working Party on Biotechnology.
Contact:
Jack Radisch
Bénédicte Callan
CASE STUDIES ON THE UPTAKE AND DIFFUSION OF HEALTH RELATED
BIOTECHNOLOGIES
The Working Party on Biotechnology will publish in Spring 2007 a study the range of incentives and barriers
that are affecting the uptake and into the health care sector of five health biotechnologies. The selected
technologies differ in their stage of development, including innovations that are relatively mature to those
that are still very new, but all have reached the market. The case studies include: monoclonal antibodies as
diagnostics and as therapeutics; genetic testsing DNA micro-arrays; and a drug delivery technology
illustrating the convergence of bio- and nano-technologies.
For each technology, the report identifies its clinical utility and factors stimulating and/or inhibiting its
diffusion. A striking finding is that in many cases the technology itself has progressed far faster than the
institutional mechanisms that are needed support widespread diffusion and uptake. For more mature
technologies, such as molecular diagnostics, the regulatory environment poses pricing problems that inhibit
dynamic investment by the private sector and price levels remain above those that would make the
technology available to broad segments of the population. Intellectual property issues pose potential
stumbling blocks to widespread uptake for several of the technologies. Lack of quality standards, uniform
clinical protocols, large-scale population studies and training of clinicians means that clinical and medical
practice has not yet adapted to the possibilities offered by the new technologies. Finally, in the bio-nano
interface (which is at a much more emergent stage than the other four) gaps in the financial infrastructure
may hinder further research needed to bring the technology to a commercial stage. The report makes clear
that institutional frameworks and technology co-evolve, and that even when breakthroughs occur diffusion
cannot be expected if the necessary institutional adjustments are not made.
Contact:
Bénédicte Callan
OECD INVITES PUBLIC COMMENTS ON GUIDELINES FOR QUALITY ASSURANCE IN
MOLECULAR GENETIC TESTING
On the basis of a comprehensive analysis of quality assurance practices in molecular genetic testing in 18
OECD countries, member countries reached agreement in 2004 to develop international best practice
guidelines. These guidelines will offer short and succinct principles and best practices that relate to quality
assurance systems, result reporting, education and training, and insofar as possible, clinical validity and
utility. The guidelines should facilitate application of best practice in relation to human genetic and genomic
testing, guarantee an international approach to exchange of clinical samples and data facilitating access to
rare disease testing, and help meet the general objectives of OECD member countries in relation to best
practices in health care.
A public consultation on a first complete draft of the guidelines was launched on 10 July 2006 and lasted six
weeks, until September 4, 2006. The Secretariat received over 90 responses from individuals and
organisations in 24 countries representing a wide range of stakeholders. Contributions included inputs from
13
government agencies, patient groups, private sector, accreditation bodies, professional associations,
academic institutions regional networks independent national and provincial organisations, hospitals and
clinical laboratories, members of relevant regional and international organisations. As with all public
consultations, while some stakeholders chose to provide only general comments supportive of the
Guidelines, others chose to also submit detailed suggestions for refining the language in the document. In
general, however the responses have been supportive of the Guidelines.
The Guidelines have since been revised on the basis of comments received .Negotiation on the final wording
of Guidelines will take place at a meeting scheduled for 15-16 January, 2007.
Web site:
www.oecd.org/sti/biotechnology
Contact:
Elettra Ronchi
BIOLOGICAL RESOURCE CENTRES
Biological resources are the foundation of all biological sciences research. They provide the source material
for scientific investigation, leading to many of the discoveries on which biotechnology is founded. A global
network of biological resource centres is a crucial part of the infrastructure that underpins advances in the
biological sciences and their capacity to contribute to sustainable growth. Science and Technology Ministers
from OECD countries have called on the Organisation to complete development of the instruments to
establish a Global Biological Resource Centre Network (GBRCN).
Biological Research Centres, once established, will:
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Make a major contribution to security by putting in place a system of quality control and tracking for
maintenance and supply of dangerous pathogens;
Provide a one-stop-shop for access to high quality biological resources for use by the bio-industry;
Help sustain the future of existing repositories of ex situ genetic resource, and thus make an
invaluable contribution to the conservation of biodiversity.
A pilot programme to ensure broader consultation on the best practices for Biological Resource Centres and
to test their practicality and practicability has been completed. A workshop to discuss the Pilot Study on Best
Practices for BRCs took place in Brussels, Belgium, on 14-15 November, 2006. The workshop
accomplished:

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Assessment of the outputs of the public consultation, and of the pilot study performed by culture
collections on best practices for BRCs.
Agreement on proposals to revise the best practices for BRCs.
Identification of options for culture collections in the implementation of the best practices for BRCs.
Formulation of a set of recommendations for the Task Force on BRCs to give guidance on further
steps of the project.
The outputs and recommendations of the above Pilot Study workshop will be submitted to the Task Force on
Biological Resource Centres at its meeting on 4-5 December, 2006.
Web site: http://www.oecd.org/biotechnology
under the theme “Scientific, Industrial and Health Applications of Biotechnology”
Contacts:
Kiyokazu Nakase
Alexandre Bartsev
14
THE OUTLOOK FOR INDUSTRIAL BIOTECHNOLOGY
Advances in biotechnology are driving a gradual change towards wider and more technologicallysophisticated use of biobased alternatives and bioprocesses across a range of industries. The transformative
ability of biotechnology, applied to industrial processes is delivering profitability and environmental gains
hand-in-hand, and the influential report The Application of Biotechnology to Industrial Sustainability
(OECD, 2001), prepared by the OECD Task Force on Biotechnology for Sustainable Industrial Development
has prompted action in several countries towards delivering a more resilient, more sustainable and more
biobased economy.
The focus at OECD on industrial biotechnology is to identify the potential contribution of biotechnology to
sustainable growth and development, and identify and appraise policy options for supply and demand side
interventions that can drive efficient economy transition. The programme is fully integrated with work on
developing statistics and economic indicators for biotechnology.
The 12th meeting of the Task Force on Biotechnology for Sustainable Industrial Development was held on
17-18 May, at the UK Department of Trade and Industry in London. The meeting engaged 20 delegates
from 12 countries and BIAC in further progressing the Task Force‘s work to develop a policy report and
recommendations on the biobased economy. Participants discussed in detail the main elements of the report,
i.e. the findings and analyses of a survey of activities in the biobased economy, conducted by the Secretariat,
and four analytical papers on key aspects of the issue.
The draft Policy Report and Recommendations on Delivering a Biobased Economy, the way to take work
forward to deliver an Outlook for Industrial Biotechnology will be discussed at the 13 th meeting of the Task
force to be held on 14-15 February, 2007, at OECD Headquarters in Paris.
Web site: http://www.oecd.org/biotechnology
under the theme “Scientific, Industrial and Health Applications of Biotechnology”
Upcoming Publication:

Policy Implications for Developing a Biobased Economy
Contact: Kiyokazu Nakse
BIOSECURITY
The Working Party on Biotechnology (WPB) decided in February 2006 to use biosecurity principles
developed by the TFBRC as the basis for further work in 2007 to analyse how best to prevent the loss or
theft of pathogens, not just as maintained in culture collections, but as relevant to a broader scope of
stakeholders. In preparation for this work, the biotechnology division of DSTI organized a “Joint
OECD/Russian Federation Workshop on Biosecurity” on 20-21 September 2006 in Moscow.
With the participation of over nearly ninety experts, the main goals of the workshop were to:

Identify opportunities for realising value from pathogenic micro-organisms.
15

Discuss the challenge of balancing the needs for controlled access to dangerous biological material
and their availability for R&D.

Initiate discussions on mutually supportive policies to support the opportunities and address the
challenges mentioned above.
Discussions at the workshop centred on the economic drivers behind the use of pathogens in biomedical
R&D, the dual-use threat of such biological materials and information associated with research on them, and
the challenge to find a balance between effective biosecurity measures and the need for an open environment
for scientific research. A fundamental point emerging from discussion was that the globalization of
biomedical R&D is growing as a result of markets for products to address infectious disease, and that such
activity now takes place in a geopolitical context wherein the menace of bioterrorism is real. Participants
concluded that there is a need for policy analysis of current approaches to pathogen security systems in line
with the notion of dual benefit, and suggested that OECD produce best practice guidelines in this area as a
tool for policymakers.
The Chairman’s Summary of the Moscow Workshop is expected to be posted on the OECD website shortly.
Web site: http://www.oecd.org/dataoecd/36/25/37492899.pdf
under the theme “Scientific, Industrial and Health Applications of Biotechnology”
Contacts: Alexandre Bartsev
Jack Radisch
BIOTECHNOLOGY STATISTICS IN OECD MEMBER COUNTRIES
The 2006 edition of OECD Biotechnology Statistics was released in June. This edition was prepared by
Brigitte van Beuzekom and Anthony Arundel of UNU-MERIT. Many others provided important
contributions to this edition, including the delegates involved in the OECD Ad hoc Meeting on
Biotechnology Statistics as well as delegates to the Working Party of National Experts on Science and
Technology Indicators (NESTI).
The current edition of OECD Biotechnology Statistics includes data for 23 OECD countries and 2 observer
countries, plus China (Shanghai), and takes a major step forward in improving the comparability of
biotechnology indicators among countries. Improvements in data collection and comparability have been
possible through the Framework for Biotechnology Statistics, developed by OECD and national experts.
Web site: http://www.oecd.org/dataoecd/51/59/36760212.pdf
Contact: Brigitte van Beuzekom
MEASURING THE OUTPUTS AND IMPACTS OF BIOTECHNOLOGY WORKSHOP
The OECD is planning a workshop on Biotechnology Outputs and Impacts on 11 December 2006 in Paris.
The workshop follows-up a May 2004 OECD meeting in Paris on the economic impacts of biotechnology.
The purpose of the upcoming December workshop is to provide a forum for progress on measuring the
socio-economic effects of biotechnology since the 2004 meeting, an assessment of measurement issues, and
an evaluation of the needs of the users of data on biotechnology impacts. The results of these three areas will
16
be used in the final workshop session to develop a framework for a future research programme to measure
the diffusion and impacts of biotechnology.
Contact: Anthony Arundel
CO-OPERATIVE RESEARCH PROGRAMME (CRP): BIOLOGICAL RESOURCE
MANAGEMENT FOR SUSTAINABLE AGRICULTURAL SYSTEMS'
The rationale of this OECD programme which gathers 26 OECD countries recognises that agriculture and
food production are heavily dependent on the application of science and that policies in these areas need to
take account of the scientific dimension. It further recognises that policy makers are often confronted by
conflicting scientific evidence and public concerns, emphasising the need for policies to be based on sound
science. The objectives of the Programme for the period 2005-2009, under a renewed mandate by Council,
are thus the following: to provide a sound scientific knowledge base to agricultural policy-making; to
contribute to an informed public debate on current and emerging agro-food issues and to help resolve
conflicting views in Member countries; and to promote scientific understanding and standards between major
regions of OECD.
Operational features of the Programme involve supporting and promoting international cooperation and
networking in the field of basic and applied research. In this respect it awards fellowships to scientists from
an OECD Member country to conduct research projects in a foreign country (OECD Member) and supports
financially workshops to address agro-food issues that are high on the science/policy agenda of OECD
Member countries. The CRP strategy emphasises the need to engage a range of scientific disciplines
including the natural sciences, social sciences and the humanities in an interactive dialogue. Three themes
will be addressed by the Programme during its mandate period:
1
2
3
The Natural Resource Challenge;
Sustainability in practice;
The Food Chain
Conferences co-sponsored by the Programme for 2006 are:
 Soils and Waste Managements: a challenge to climate change, Gorizia, Italy 15-16 June 2006
 Beyond the “Blue Book” Recombinant DNA Safety Considerations Celebrating the twentieth
anniversary of international work on biosafety at the OECD, Ramada Plaza Hotel, Jeju Island
Korea 29 September 2006
 The role of Rumen biohydrogenation in the production of nutritionally enhanced ruminant derived
foods by sustainable means, University of Madrid Spain, 30 September – 1 October 2006
 International Workshop on 'Domestication, super-domestication and gigantism: human
manipulation of plant genomes for increasing crop yield, Tsukuba Japan 2- 4 October 2006
 Forestry: A Sectoral response to climate change, Wilton Park UK 21-23 November 2006
 Mycotoxins from the Field to the Table, Doubletree Conference Centre, Omaha Nebraska USA
28 November – 1 December 2006
A workshop is planned for early 2007 to identify the “state of play” regarding the relevant economic,
environmental and policy issues that may warrant further examination by governments as they consider the
future developments in production, consumption and trade of bioenergy. While scientific and environmental
issues will be addressed, the focus of the workshop will be on the relatively less developed questions relating
to the economic and policy implications of a possible increase in the use of bioenergy.
The workshop will be managed by the Directorate for Food, Agriculture and Fisheries, in collaboration with
other members of the ICGB, including the International Future’s Programme, the International Energy
Agency, CMET, and the Directorates for Science, Technology and Industry, Environment, and Trade. Target
participants include science, environment and economic experts and policy advisors, from both OECD and
17
non-OECD countries. The programme will be partly financed through funding from the Co-operative
Research Programme. The proceedings will be produced and distributed by OECD.
Information on the Co-Operative Research Programme and application forms for conference sponsorship or
Research Fellowship awards are available on the Programme website:
http://www.oecd.org/topic/0,2686,en_2649_33903_1_1_1_1_37401,00.html
Recent Publications
th
 8 International Conference on Shellfish Restoration, 2-5 October 2005, Brest France.
 Crop Ferality and volunteerism: A threat to Food Security in the Transgenic Era? Bellagio, Como Italy,
24-29 May 2004 (ISBN O-8493-2895-0-900000)
 Anticholinesterasa agents, health and sustainable agriculture. A specialized session of the VIIIth
International Meeting on Cholinesterases, Perugia, Italy ,26-30 September 2004 (ISSN 0009-2797 157158-1-434)
 Phytoremediation: Environmental and Molecular Biological Aspects,
Keszthely, Hungary, 9-12
September 2004 (ISSN 0939-5075)
TH
 4 Joint INRA-RRI Symposium Gut Microbiology: Concerns and responses to Food Safety, Health and
Environmental Issues 21-24 June Clermond-Ferrand, France (ISSN 0926-5287)
 Rhizosphere 2004: Perspectives and Challenges - A tribute to Lorenz Hiltner, Munich Germany, 12-17
September 2004 GSF Bericht 05/05
 Improving the Balance Between Economic Agricultural Production and Environmental Quality through
Enhanced Decision Making, Hawaï, United States, 9-11 November 2004 (ISBN 0-9769432-1-2)
 The Assessment of Food Quality from Cloned Animals INRA Jouy-en-Josas 21-23 November 2003
Cloning and Stem Cells Volume 6 Number 2 ISSN 1536-2302
 Integration of European Food Safety Research from producers to consumers: conference proceedings
of 2 Conferences on Food Safety: "Food: new challenges after a century of progress", Headquarters of
the Société Scientifique d'Hygiène alimentaire, Paris France, 17-18 June 2004 and "Integrating Safety
and Nutrition Research along the Food Chain: the new challenge", Lille, October 27-29 2004.
Forthcoming publications linked to conferences held in 2005:
 Agricultural and societal implications of contemporary embryo-technologies in farm animals,
Copenhagen, Denmark 12 January 2005
Contacts: Liliane Shettle
Caroline Keogh
OECD'S SEED CERTIFICATION AND FOREST REPRODUCTIVE MATERIAL SCHEMES
The following three criteria namely; distinctness, uniformity and stability are used for defining crop varieties
and form the basis for agricultural seed development and trade. Identification and minimum purity criteria are
important components of sustainability, especially in the case of hybridisation and genetic modifications. For
forest reproductive material reliability depends on several factors including local identification, regions or
provinces, selection and breeding.
The OECD Seed Schemes were developed in the late 1950s to regulate international exchanges, as well as
“counter season” multiplication of seed, particularly between the northern and southern hemispheres. They
are implemented by member and non-member countries across all continents. For example, Kyrgyzstan and
Albania became the 54th and 55th participants in the Schemes in December 2005. In essence, the Schemes
attempt to harmonise certification with a view to facilitating international trade in agricultural seeds. Over
191 species, including all the basic staples and 36 800 varieties appear on the latest OECD List of Varieties
18
Eligible for Certification. Among the emerging issues are the role of government in the control and testing of
seeds, the accreditation of authorised private field inspectors and laboratories, the impact of biotechnology
and advanced breeding methods on seed certification, the certification of seed mixtures (herbage species,
hybrid maize, swede rape), seed lot size and homogeneity, and the issue of barcodes on OECD seed labels.
A Workshop on Seed Certification and Modern Biotechnology took place in September 2005 in Paris.
The four sub-themes were; Varietal Identity, Varietal Purity, Seed Quality and Government Roles. More than
100 participants took part in the workshop including officials from 43 countries and organisations. It was
agreed to establish a new “Working Group on Varietal Purity and Varietal Identity” in 2006, with the broad
mandate to assess the current and future needs of international certification, including developments on
genetically modified seeds.
Contacts have been developed with the Secretariat of the Convention on Biological Diversity (CBD) on
issues related to compliance with the Cartagena Protocol on Biosafety. Similarly, contacts have been made
with the International Federation for Organic Agricultural Movement (IFOAM) on organic seed standards.
A new OECD Scheme for the Certification of Forest Reproductive Material is currently being
introduced. In 2004, a database of basic reproductive material (forest stands, etc.) available in participating
countries was set up on the website.
Future events:

Meeting of the extended Advisory Group/Agricultural Seed (22-23 January 2007, Paris, France)

2nd Meeting of the Working Group on Varietal Identity and Varietal Purity (24 Jan.07, Paris, France)

Annual Meeting of National Designated Authorities/Agric. Seed (11-12 July 2007, Paris, France)

Meeting of National Designated Authorities/Forest Reproductive Material (27-28 September 07, Paris)
Publications:
 List of Varieties Eligible for Seed Certification 2005/2006 (next List 2006/2007 to be issued in Dec.06)
 OECD Seed Schemes “2006”
Web sites: http://www.oecd.org/agr/seed
http://www.oecd.org/agr/forest
Contact: Michael Ryan
Bertrand Dagallier
OECD BIOTECHNOLOGY AND THE WORLD WIDE WEB
OECD’s web site includes much information on biotechnology, biosecurity, biosafety and related topics. The
web site allows individual users to tailor the OECD site to their needs. By selecting the themes that interest
them, visitors can personalize their homepages at My OECD to present the news, events, and documentation
related to their chosen themes. Visitors can also choose to receive automatically future editions of
Biotechnology Update through My OECD.
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
OECD’s portal is: http://www.oecd.org
OECD’s biotechnology portal: http://www.oecd.org/biotechnology
For more information on industrial, scientific and health applications of biotechnology, and Biosecurity,
see: http://www.oecd.org/biotechnology/ under the theme “Scientific, Industrial and Health Applications
of Biotechnology.”
The BioTrack information system (which covers biosafety) is found at: http://www.oecd.org/biotrack/
For information on Biosecurity codes of conduct, see: www.biosecuritycodes.org
Hard copies of many OECD publications can be obtained free-of-charge from the ICGB Secretariat.
19
NANOTECHNOLOGIES AND THE SAFETY OF MANUFACTURED NANOMATERIALS
Recently, there has been much public discussion about nanotechnologies which are set to offer a wide range
of economic benefits. At the same time, they pose new policy challenges to governments. Using its
multidisciplinary approach, the OECD is working on policies and instruments that foster the development of
nanotechnologies in an efficient and an effective a way as possible.
To this end, two OECD Committees, the Chemicals Committee and the Committee for Scientific and
Technological Policy have started complementary activities. These co-ordinated and mutually supporting
efforts should help provide the conditions for optimal development of this exciting range of new
technologies.
As nanotechnologies are relevant already to two OECD Committees, it has been agreed that the Internal
Coordination Group for Biotechnology (ICGB), will also be the co-ordination mechanism for
nanotechnologies. This should allow the identification of synergies across OECD directorates and relevant
Committees, while avoiding duplication.
COMMITTEE FOR SCIENTIFIC AND TECHNOLOGICAL POLICY (CSTP)
Work on Nanotechnologies under the Committee for Scientific and Technological Policy
Much of the recent public discussion about nanotechnologies has concerned applications for the future.
However, estimated annual public R&D expenditure already exceeds USD 4 billion and a number of
products are already on the market. At the same time, they pose new policy challenges to governments.
OECD’s Committee on Scientific and Technological Policy is focusing on creating supportive frameworks
for innovation on nanotechnologies. The CSTP discussed its future work on nanotechnologies in October
2006 and decided, in principle, to propose the creation of a new working party on nanotechnologies. It will
hold a workshop in February 2007, in the Netherlands, to develop the terms of reference of this proposed
group and establish a work programme. The activities of the CSTP would seek to achieve, amongst other
things, a better understanding of how best to promote research, development and innovation of
nanotechnologies, the possible uses and commercialisation of products from this research, how different
applications of nanotechnologies might appropriately develop, as well as the development of statistics and
indicators to track the development of nanotechnologies. This work should help foster good policy making
and governance of technological developments in OECD member countries.
Contacts: Dirk Pilat
Iain Gillespie
CHEMICALS COMMITTEE: WORKING PARTY ON MANUFACTURED NANOMATERIALS
(WPMN)
The OECD Working Party on Manufactured Nanomaterials (WPMN) is a subsidiary body of the Chemicals
Committee. This programme aims to promote international co-operation on the human health and
20
environmental safety of manufactured nanomaterials, and involves approaches to the safety testing and risk
assessment of manufactured nanomaterials.
The 1st Meeting of the WPMN was held the 26th-27th October in London, United Kingdom. The main
outcome of this meeting was a Programme of Work that has been endorsed by the 40 th Chemicals Committee
(15-17 November 2006). The Programme of Work addresses three main areas listed as follows: 1)
Identification, Characterisation, Definitions, Terminology and Standards; 2) Testing Methods and Risk
Assessment; and 3) Information sharing, Co-operation and Dissemination.
The WPMN has started to implement the programme of work through different projects, which will lead to:
i) the development of a database on human health and environmental safety (EHS) research related to
manufactured nanomaterials; ii) the development of a global strategy for EHS research on manufactured
nanomaterials; iii) the testing of a representative set of manufactured nanomaterials; iv) the evaluation of the
suitability of existing OECD test guidelines (chemical safety) for nanomaterials; v) information exchange on
national regulatory programmes and voluntary regulatory schemes; and vi) co-operation on risk assessment
and undertaking exposure measurements.
Progress on each of these projects will be discussed at the 2nd Meeting of WPMN (end of April 2007).
Recent Publication:
 Current Developments/ Activities on the Safety of Manufactured Nanomaterials, November 2006
Other publication:
 The Report of the OECD Workshop on the Safety of Manufactured Nanomaterials: Building Cooperation, Co-ordination and Communication, 7-9 December 2005
Website: www.oecd.org/env/nanosafety
www.oecd.org/env/nanosecurite
Contact: Peter Kearns
FUTURE EVENTS
 Task Force on Biological Resource Centres, Paris, 4-5 December 2006 (Contact: Kiyokazu Nakase and
Alexandre Bartsev)
 Expert meeting on Health Innovation Survey, Paris, 8 December 2006 (Contact: Bénédicte Callan)
 Workshop on Measuring the Outputs and Impacts of Biotechnology, Paris, 11 December 2006 (Contact:
Anthony Arundel)
 Expert meeting on Guidelines on Quality Assurance of Genetic Testing, Paris, 15-17 January 2007
(Contact: Elettra Ronchi)
 OECD Workshop on Bioenergy Policy Analysis, Umea, Sweden, 22-23 January 2007. (Contact: Martin
von Lampe)
 Task Force on Biotechnology for Sustainable Industrial Development, Paris, 15-16 February 2007
(Contact: Kiyokazu Nakase)
 Working Party on Biotechnology, Paris, 19-20 February 2007 (Contact: Bénédicte Callan)
 Working Group on Human-Health Related Biotechnology, Paris, 21 February 2007 (Contact: Benedicte
Callan, Elettra Ronchi)
 19th Meeting of the Working Group for the Harmonisation of Regulatory Oversight in Biotechnology,
Paris, France, 21-23 February 2007 (Contact: Masatoshi Kobayashi)
 89th Session of the Committee for Scientific and Technological Policy, Paris, France, 26-27 March 2007
(Contact: Dirk Pilat)
21
 2nd Meeting of the Working Party on Manufactured Nanomaterials, Berlin, Germany, 25-27 April 2007
(contact: Peter Kearns)
 13th Meeting of the Task Force for the Safety of Novel Foods and Feeds, Paris, France, 27-29 June 2007
(Contact: Mar Gonzalez)
WHO’S WHO IN BIOTECH AT OECD
Michael OBORNE (SGE/AU)
Chairman of the ICGB
Director Multidisciplinary Issues and the International Futures Program
Peter KEARNS (ENV/EHS)
Secretary to the ICGB
Head of the Programme on the Safety on Manufactured Nanomaterials
Head of Biosafety Programme
Harmonisation of Regulatory Oversight in Biotechnology
Safety of Novel Foods and Feeds
Anthony ARUNDEL (STI/EAS)
Biotechnology Impacts Workshop
Alexandre BARTSEV (STI/BIO)
Biological Resource Centres
Biosecurity (General)
Benedicte CALLAN (STI/BIO)
Biotechnology, Innovation and Health
Emerging and Neglected Disease
Andrew DAVIS (GOV/RCG)
Clusters
Iain GILLESPIE (STI/BIO)
Head of Biotechnology Division
Working Party on Biotechnology
Mar GONZALEZ (ENV/EHS)
Safety of Novel Foods and Feeds
Safety on Manufactured Nanomaterials
Harmonisation of Regulatory Oversight in Biotechnology
Stella HORSIN (STI/BIO)
Working Party on Biotechnology
Masatoshi KOBAYASHI (ENV/EHS)
BioTrack Online
Harmonisation of Regulatory Oversight in Biotechnology
Kiyokazu NAKASE (STI/BIO)
Biological Resource Centres
Sustainable Industrial Development
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Dirk PILAT (STI/STP)
Head of the Science and Technology Policy Division
Committee on Science and Technology Policy
Jack RADISCH (STI/BIO)
Biotechnology, Innovation and Health
Biosecurity
Elettra RONCHI (STI/BIO)
Quality Assurance of Genetic Testing
Pharmacogenetics
Michael RYAN (AGR/COD)
Head, Agricultural Codes and Schemes (Seed Schemes, Forest Reproductive Material Scheme, Tractor
Codes, Fruit and Vegetable Scheme).
Christina SAMPOGNA (STI/BIO)
Intellectual Property Rights (IPRs)
Collaborative IPR Mechanisms
Human Genetic Research Databases
Counterfeiting of Pharmaceuticals
David SAWAYA (SGE/AU)
The Bioeconomy to 2030
Biosecurity
Liliane SHETTLE (AGR/CMU)
Cooperative Research Programme
Noriko OKI (EHS/ENV)
Safety of Manufactured Nanomaterials
Brigitte VAN BEUZEKOM (STI/EAS)
Biotechnology Statistics
Martin VON LAMPE (AGR/TM)
Workshop on bioenergy policy analysis
CONTACT POINT:

Peter Kearns
Secretary, ICGB
OECD
2 rue André-Pascal
75775 PARIS Cedex 16
France
Tel:
(33-1) 45 24 16 77
Fax:
(33-1) 45 24 16 75
E-mail: Peter.Kearns@oecd.org
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MEDIA ENQUIRIES:

Helen Fisher
OECD, Communications
2 rue André-Pascal
75775 PARIS Cedex 16
France
Tel:
(33-1) 45 24 80 97
Fax:
(33-1) 45 24 94 37
E-mail: Helen.Fisher@oecd.org
ENDNOTE: A BRIEF GUIDE TO THE OECD
The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental
organisation with 30 member countries. Its principal aim is to promote policies for sustainable economic
growth and employment, a rising standard of living, and trade liberalisation. By sustainable economic growth
the OECD means growth that balances economic, social and environmental considerations.
The OECD is an institution that enables its member countries to discuss and develop both domestic and
international policies. It analyses issues, recommends actions, and provides a forum in which countries can
compare their experiences, seek answers to common problems, and work to co-ordinate policies. An
increasing number of non-member countries participate in a wide range of activities, including some of those
related to biotechnology.
The Council of OECD is the highest decision-making body of the Organisation. Its members are the
Ambassadors of the Member countries to OECD. It is chaired by OECD’s Secretary-General. Once a year, it
meets at the level of Ministers from member countries. Amongst other things, the Council decides on the
annual budget of Organisation as well as the content of the programme of work.
In addition to the Council, there are around 200 specialised Committees and other bodies (including Working
Parties, Working Groups, and Task Forces), which undertake the Organisation’s programme of work. The
governments of the Member countries nominate the participants to all these groups.
The list below shows the main OECD bodies that have activities related to biotechnology:
OECD Council
Committee for Agriculture (COAG)
 Seeds Scheme
 Co-operative Research Programme
Committee for Scientific and Technological Policy (CSTP)
 Working Party on Biotechnology
 Working Group on Human-Health-Related Biotechnologies
 Task Force on Biological Resource Centres
 Task Force on Biotechnology for Sustainable Industrial Development
Environment Policy Committee (EPOC)
 Working Group on Economic Aspects of Biodiversity
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Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and
Biotechnology (Joint Meeting)
 Working Group for the Harmonisation of Regulatory Oversight in Biotechnology
 Task Force for the Safety of Novel Foods and Feeds
The list below shows the recently established OECD body that has activities related to nanotechnologies:
OECD Council
Chemicals Committee (Joint Meeting of the Chemicals Committee and the Working Party on
Chemicals, Pesticides and Biotechnology)
 Working Party on the Safety of Manufactured Nanomaterials
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